Scott Gottlieb, commissioner of the U.S. Food and Drug Administration, announced on Friday that the agency is going to force cigarette manufacturers to reduce the level of nicotine in their products to make them less addictive.
More importantly, he said the FDA was delaying regulation of e-cigarettes and, instead, urging makers of those products to have them designated and regulated as smoking cessation products.
This is a sea change in the war on smoking – a dramatic shift from an abstinence-only approach to a harm-reduction philosophy.
"Nicotine lives at the core of both the problem and the solution to the question of addiction," Dr. Gottlieb said.
It's hard to overstate the importance of that comment.
Nicotine is highly addictive. It's what keeps smokers smoking. But, compared to the other 7,000 or so chemicals in tobacco smoke, nicotine is relatively benign. It's the products of combustion such as tar and carbon monoxide that cause cancer, lung disease and cardiovascular disease.
If you want people to stop dying – and let's not forget there are 480,000 tobacco-related deaths in the U.S. and 40,000 more in Canada annually – then you need to limit their exposure to the smoke they inhale.
For many years now, public-health officials have pursued a dogmatic "quit or die approach" – to quote David Sweanor, a long-time public-health advocate and University of Ottawa adjunct professor.
This prohibitionist tack has worked relatively well, with smoking rates falling steadily from almost 50 per cent in the 1960s to 15 per cent today.
But we seem to be stuck at this 15-per-cent level – and the main reason is that hard-core smokers are addicted to nicotine. You can hide tobacco products out of sight in stores, ban smoking in the workplace, introduce graphic warnings and plain packages, outlaw tobacco advertising, hike tobacco taxes, banish smoking in bars, restaurants, patios, parks, beaches and so on.
But, despite the hurdles and sanctions, addicts will get their fix.
The FDA's new approach to regulation recognizes this grim reality.
It acknowledges that if you want people to stop smoking, the most effective way to do so is to provide them with another source of nicotine.
And if you want people to not get hooked on cigarettes in the first place, you need to have non-addictive levels of nicotine in tobacco – in addition to other public-health measures.
What the FDA is proposing is to do both.
"Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it's vital that we pursue this common ground," Dr. Gottlieb said.
The FDA does not have the legal power to ban tobacco, or to mandate zero nicotine in tobacco. But it can order manufacturers to reduce nicotine to non-addictive levels. The technology exists. But the regulations will be fiercely resisted by Big Tobacco and probably by smokers. (Low-nicotine cigarettes have been marketed before and flopped.)
The FDA can also make it easier for smokers to get their nicotine fix from e-cigarettes – and it has chosen to do so mostly by getting out of the way.
The vaping market is burgeoning but the FDA was set to implement strict regulatory controls – forcing all products introduced since 2007 to be reviewed and approved by May, 2019. Practically, that would have meant that most vaping products would become illegal because few small companies can afford the costs of regulatory review.
Dr. Gottlieb announced that manufacturers now have to submit applications for approval of vaping products by 2022, but can remain on the market until then.
The downside of this is that many second-rate products will remain on the market and some vaping companies will continue to target kids with flavours such as Tutti Frutti and gummy bear.
But the FDA will also take the time to regulate wisely, including allowing manufacturers to ask to be listed as smoking cessation products.
That, in itself, is huge.
There is growing evidence that smokers – who, for the most part, wish they could quit – are turning to vaping, and it's working. As always, the public is one step ahead of the regulator.
Many anti-smoking activists, however, consider e-cigarettes as evil as cigarettes and, far too often, they've overblown the risks of vaping. That's wrong-headed and counterproductive.
Prohibition doesn't work – whether we're talking opioids or tobacco. Harm reduction, though it often makes us uncomfortable, does work.
Smoking low-nicotine cigarettes is better than smoking high-nicotine ones, and vaping is better than smoking.
Those are the kind of plain language messages that regulators and public-health officials need to deliver in Canada, not just the U.S.